Trial Outcomes & Findings for Home Study of an Advanced Upper Limb Prosthesis (NCT NCT01551420)
NCT ID: NCT01551420
Last Updated: 2019-04-30
Results Overview
The QOL consists of 16 questions that assess satisfaction with independent living and self-care activities. Each item is rated (1=Terrible to 7=Delighted). The average of these 16 items is the summary score with higher values reflecting higher satisfaction. The primary outcome is the net change in summary score between baseline and end of Part B.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
baseline and after 9-12 weeks of home use (end of Part B)
Results posted on
2019-04-30
Participant Flow
Participant milestones
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
In-laboratory (Part A)
STARTED
|
39
|
13
|
|
In-laboratory (Part A)
COMPLETED
|
33
|
11
|
|
In-laboratory (Part A)
NOT COMPLETED
|
6
|
2
|
|
Screened for Part B Eligibility
STARTED
|
33
|
11
|
|
Screened for Part B Eligibility
COMPLETED
|
24
|
8
|
|
Screened for Part B Eligibility
NOT COMPLETED
|
9
|
3
|
|
Home Use (Part B)
STARTED
|
24
|
8
|
|
Home Use (Part B)
COMPLETED
|
18
|
7
|
|
Home Use (Part B)
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
In-laboratory (Part A)
Lost to Follow-up
|
2
|
1
|
|
In-laboratory (Part A)
Withdrawal by Subject
|
2
|
0
|
|
In-laboratory (Part A)
Scheduling conflict
|
2
|
1
|
|
Screened for Part B Eligibility
Declined participation
|
8
|
1
|
|
Screened for Part B Eligibility
Deemed ineligible by staff
|
1
|
2
|
|
Home Use (Part B)
Withdrawal by Subject
|
6
|
0
|
|
Home Use (Part B)
Withdrawal by staff
|
0
|
1
|
Baseline Characteristics
Home Study of an Advanced Upper Limb Prosthesis
Baseline characteristics by cohort
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=39 Participants
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=13 Participants
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and after 9-12 weeks of home use (end of Part B)The QOL consists of 16 questions that assess satisfaction with independent living and self-care activities. Each item is rated (1=Terrible to 7=Delighted). The average of these 16 items is the summary score with higher values reflecting higher satisfaction. The primary outcome is the net change in summary score between baseline and end of Part B.
Outcome measures
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=17 Participants
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=7 Participants
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
Change in Quality of Life (QOL) Scale
|
5.8 score on a scale
Standard Deviation 0.7
|
5.3 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)Population: Prosthesis users only, at baseline, completers at End of A and End of B.
Measures the engagement of the prosthesis in everyday activities using 23 items from the OPUS UEFS. Respondents indicate which activities they performed using a prosthesis. The score is the proportion of activities performed using a prosthesis.
Outcome measures
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=39 Participants
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=13 Participants
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale
Prosthesis users at baseline
|
0.3 proportion of activities performed
Standard Deviation 0.3
|
0.4 proportion of activities performed
Standard Deviation 0.3
|
|
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale
Completers End of Part A
|
0.7 proportion of activities performed
Standard Deviation 0.3
|
0.6 proportion of activities performed
Standard Deviation 0.3
|
|
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale
Completers End of B
|
0.6 proportion of activities performed
Standard Deviation 0.2
|
0.1 proportion of activities performed
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)Population: Prosthesis users only, at baseline, completers at End of A and End of B.
The TAPES Satisfaction scale is a 10-item scale measuring extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated from 1-5 (1=Very Dissatisfied to 5=Very Satisfied). The average score is used.
Outcome measures
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=33 Participants
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=12 Participants
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale
Prosthesis users at baseline
|
3.6 score on a scale
Standard Deviation 0.7
|
3.7 score on a scale
Standard Deviation 0.8
|
|
Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale
Completers End of Part A
|
3.5 score on a scale
Standard Deviation 0.7
|
3.0 score on a scale
Standard Deviation 0.6
|
|
Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale
Completers End of B
|
3.8 score on a scale
Standard Deviation 0.9
|
2.7 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)Population: Prosthesis users only, at baseline, completers at End of A and End of B.
The AM-ULA is an 18-item measure assessing functional performance with a prosthesis: ability of the amputee to complete daily activities, speed of the performance, movement quality, skillfulness of prosthetic use and independence. Items are rated 0=Unable to perform task to 4=Excellent Performance. Average score is multiplied by 10 and has a range from 0 (lowest functional performance) to 40 (highest functional performance).
Outcome measures
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=33 Participants
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=11 Participants
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
Activities Measure for Upper Limb Amputees (AM-ULA)
Prosthesis users at baseline
|
17.5 units on a scale
Standard Deviation 6.1
|
10.4 units on a scale
Standard Deviation 3.3
|
|
Activities Measure for Upper Limb Amputees (AM-ULA)
Completers End of Part A
|
16.8 units on a scale
Standard Deviation 4.5
|
16.8 units on a scale
Standard Deviation 3.1
|
|
Activities Measure for Upper Limb Amputees (AM-ULA)
Completers End of B
|
10.7 units on a scale
Standard Deviation 4.4
|
19.8 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)Population: Baseline participants and completers at End of A and End of B
Role Physical: measures role physical function with 4 items referring to role limitations due to physical health. Items are rated from 1=none of the time to 5=All of the time. Social Functioning: measures social functioning with 2 items referring to problems interfering with socializing with friends and family. One item is rated extent of problems as 1=Not at all to 5=Extremely and is reverse coded. All other items are rated as problem frequency from 1=All of the time to 5=None of the time. The mean score is scaled to range between 0 to 100. Physical Functioning: measures physical functioning with 10 items pertaining to moving, lifting and walking. Items are rated from 1=Limited a lot to 3=Not limited at all. The mean score is scaled to range between 0 to 100. In all scales, higher scores correspond to higher quality of life.
Outcome measures
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=39 Participants
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=13 Participants
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
Three Scales of the Veterans Version of the SF-36
Role Physical: Participants at Baseline
|
80.0 score on a scale
Standard Deviation 18.8
|
74.5 score on a scale
Standard Deviation 24.3
|
|
Three Scales of the Veterans Version of the SF-36
Role Physical:Completers at End of Part A
|
77.8 score on a scale
Standard Deviation 21.5
|
71.3 score on a scale
Standard Deviation 25.7
|
|
Three Scales of the Veterans Version of the SF-36
Role Physical: Completers at End of B
|
82.2 score on a scale
Standard Deviation 17.7
|
72.3 score on a scale
Standard Deviation 22.2
|
|
Three Scales of the Veterans Version of the SF-36
Social Functioning: Participants at Baseline
|
88.5 score on a scale
Standard Deviation 18.0
|
86.5 score on a scale
Standard Deviation 13.9
|
|
Three Scales of the Veterans Version of the SF-36
Social Functioning: Completers at End of Part A
|
86.4 score on a scale
Standard Deviation 23.3
|
77.5 score on a scale
Standard Deviation 19.4
|
|
Three Scales of the Veterans Version of the SF-36
Social Functioning: Completers End of B
|
86.8 score on a scale
Standard Deviation 15.9
|
80.4 score on a scale
Standard Deviation 18.9
|
|
Three Scales of the Veterans Version of the SF-36
Physical Functioning: Participants at Baseline
|
82.6 score on a scale
Standard Deviation 15.8
|
68.8 score on a scale
Standard Deviation 22.5
|
|
Three Scales of the Veterans Version of the SF-36
Physical Functioning: Completers at End of Part A
|
80.4 score on a scale
Standard Deviation 18.2
|
68.5 score on a scale
Standard Deviation 24.2
|
|
Three Scales of the Veterans Version of the SF-36
Physical Functioning: Completers at End of B
|
82.6 score on a scale
Standard Deviation 18.4
|
55.7 score on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)Population: Prosthesis users only, at baseline, completers at End of A and End of B.
JTHFT Writing: Evaluates the time needed to print a 24-letter, third-grade reading difficulty sentence. JTHFT Page turning: Evaluates the time needed to turn over 7.6 x 12.7 cm (3x5") cards in simulated page turning. JTHFT Small objects: Evaluates the time needed to perform pick up small common objects including pennies, paper clips, bottle caps and placing them in a container. JTHFT Stacking checkers: Evaluates the time needed to stack four checkers. JTHFT Simulated feeding: Evaluates the time needed to perform simulated feeding. JTHFT Moving large empty cans: Evaluates the time needed to move large empty cans. JTHFT Moving large 1 lb. cans: Evaluates the time needed to move 1 lb. cans. All subtests are modified to cap the maximal time for the subtask at 120 seconds and is scored as the number of items completed per second.
Outcome measures
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=33 Participants
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=11 Participants
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Writing: Prosthesis users at baseline
|
0.37 items completed per second
Standard Deviation 0.24
|
0.37 items completed per second
Standard Deviation 0.17
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Writing: Completers at End of Part A
|
0.35 items completed per second
Standard Deviation 0.18
|
0.39 items completed per second
Standard Deviation 0.12
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Writing: Completers End of B
|
0.45 items completed per second
Standard Deviation 0.19
|
0.42 items completed per second
Standard Deviation 0.16
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Page Turning: Prosthesis users at baseline
|
0.09 items completed per second
Standard Deviation 0.08
|
0.10 items completed per second
Standard Deviation 0.03
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Page Turning: : Completers at End of Part A
|
0.05 items completed per second
Standard Deviation 0.04
|
0.06 items completed per second
Standard Deviation 0.03
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Page Turning: Completers End of B
|
0.10 items completed per second
Standard Deviation 0.07
|
0.07 items completed per second
Standard Deviation 0.03
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Small Items: Prosthesis users at baseline
|
0.08 items completed per second
Standard Deviation 0.08
|
0.07 items completed per second
Standard Deviation 0.06
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Lifting Small Items:: Completers End of Part
|
0.07 items completed per second
Standard Deviation 0.07
|
0.04 items completed per second
Standard Deviation 0.03
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Lifting Small Items: Completers End of B
|
0.08 items completed per second
Standard Deviation 0.06
|
0.06 items completed per second
Standard Deviation 0.06
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Checkers: Prosthesis users at baseline
|
0.12 items completed per second
Standard Deviation 0.08
|
0.12 items completed per second
Standard Deviation 0.06
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Checkers: Completers End of Part A
|
0.07 items completed per second
Standard Deviation 0.06
|
0.06 items completed per second
Standard Deviation 0.05
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Checkers: Completers End of B
|
0.09 items completed per second
Standard Deviation 0.08
|
0.11 items completed per second
Standard Deviation 0.04
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Feeding: Prosthesis users at baseline
|
0.11 items completed per second
Standard Deviation 0.09
|
0.12 items completed per second
Standard Deviation 0.06
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Feeding: Completers End of Part A
|
0.07 items completed per second
Standard Deviation 0.06
|
0.05 items completed per second
Standard Deviation 0.05
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Feeding: Completers End of B
|
0.10 items completed per second
Standard Deviation 0.07
|
0.05 items completed per second
Standard Deviation 0.03
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Light Cans: Prosthesis users at baseline
|
0.21 items completed per second
Standard Deviation 0.15
|
0.22 items completed per second
Standard Deviation 0.08
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Light Cans: Completers End of Part A
|
0.19 items completed per second
Standard Deviation 0.15
|
0.10 items completed per second
Standard Deviation 0.08
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Light Cans: Completers End of B
|
0.24 items completed per second
Standard Deviation 0.16
|
0.14 items completed per second
Standard Deviation 0.06
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Heavy Cans: Prosthesis users at baseline
|
0.24 items completed per second
Standard Deviation 0.17
|
0.24 items completed per second
Standard Deviation 0.11
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Heavy Cans: Completers End of Part A
|
0.20 items completed per second
Standard Deviation 0.15
|
0.13 items completed per second
Standard Deviation 0.09
|
|
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
JTHFT Heavy Cans: Completers End of B
|
0.28 items completed per second
Standard Deviation 0.15
|
0.16 items completed per second
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)Population: Prosthesis users only, at baseline, completers at End of A and End of B.
This test is performed with unilateral amputees only. The subtest used includes wrapping a parcel, sewing a button on cloth, cutting meat, drying dishes, sweeping floor, and using a dustpan and brush. Each task was rated for both spontaneity and skill. UNB Spontaneity: Spontaneity rates spontaneity of prosthesis use (0=prosthesis not used to 4=immediate, consistent use of terminal device. UNB Skill: rates skill of performing the activities (0 = prothesis not used to 4 = active terminal device is quick \& smooth). Summary scores are calculated for each subscale by averaging items and range from 0 to 4 with higher scores reflecting higher spontaneity and skill.
Outcome measures
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=31 Participants
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=11 Participants
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
University of New Brunswick Test of Prosthetic Function (UNB)
UNB Spontanaity: Prosthesis users at baseline
|
3.1 score on a scale
Standard Deviation 0.5
|
3.2 score on a scale
Standard Deviation 0.4
|
|
University of New Brunswick Test of Prosthetic Function (UNB)
UNB Spontanaity: Completers End of Part A
|
3.0 score on a scale
Standard Deviation 0.4
|
3.1 score on a scale
Standard Deviation 0.5
|
|
University of New Brunswick Test of Prosthetic Function (UNB)
UNB Spontaneity: Completers End of Part B
|
3.2 score on a scale
Standard Deviation 0.4
|
3.4 score on a scale
Standard Deviation 0.3
|
|
University of New Brunswick Test of Prosthetic Function (UNB)
UNB Skill: Prosthesis users at baseline
|
3.0 score on a scale
Standard Deviation 0.5
|
3.0 score on a scale
Standard Deviation 0.5
|
|
University of New Brunswick Test of Prosthetic Function (UNB)
UNB Skill: Completers End of Part A
|
2.8 score on a scale
Standard Deviation 0.5
|
2.9 score on a scale
Standard Deviation 0.5
|
|
University of New Brunswick Test of Prosthetic Function (UNB)
UNB Skill: Completers End of Part B
|
3.1 score on a scale
Standard Deviation 0.4
|
3.2 score on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)Population: Baseline participants and completers at End of A and End of B
The T-MAP is a performance measure of daily activities for persons with upper limb amputation utilizing 5 every day activities. Time (seconds) to completion of activity is measured and summed to obtain overall timed score. Lower overall scores (less time taken) indicate better / faster activity performance
Outcome measures
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=39 Participants
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=13 Participants
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
Timed Measure of Activity Performance (T-MAP)
Prosthesis users at baseline
|
459.8 Seconds
Standard Deviation 223.6
|
366.5 Seconds
Standard Deviation 108.5
|
|
Timed Measure of Activity Performance (T-MAP)
Completers End of Part A
|
748.1 Seconds
Standard Deviation 461.7
|
549.0 Seconds
Standard Deviation 257.5
|
|
Timed Measure of Activity Performance (T-MAP)
Completers End of Part B
|
624.8 Seconds
Standard Deviation 429.1
|
443.3 Seconds
Standard Deviation 154.2
|
SECONDARY outcome
Timeframe: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)Population: Baseline participants and completers at End of A and End of B.
The UEFS is a self-report measure developed for use with upper limb adult amputees. It includes 23 activities: selfcare, instrumental, and daily living tasks using a 5-point scale from 1=Very Easy to 5=Cannot perform. Total score was calculated using IRT methods and ranged from 0 to 100 with lower scores reflecting better function.
Outcome measures
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=27 Participants
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=10 Participants
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS)
Prosthesis users at baseline
|
42.4 score on a scale
Standard Deviation 8.1
|
37.6 score on a scale
Standard Deviation 14.9
|
|
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS)
Completers End of Part A
|
44.3 score on a scale
Standard Deviation 6.3
|
45.8 score on a scale
Standard Deviation 8.2
|
|
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS)
Completers End of Part B
|
38.0 score on a scale
Standard Deviation 9.5
|
41.5 score on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)Population: Baseline participants and completers at End of A and End of B
The CRIS measures community reintegration. It consists of three scales extent and frequency, perceived limitations, and satisfaction. Higher scores (range 0-100) indicate better community integration.
Outcome measures
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=38 Participants
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=13 Participants
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
CRIS Satisfaction: Baseline
|
54.0 score on a scale
Standard Deviation 11.2
|
48.6 score on a scale
Standard Deviation 6.5
|
|
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
CRIS Extent of Participation: Baseline
|
53.8 score on a scale
Standard Deviation 8.1
|
53.1 score on a scale
Standard Deviation 9.1
|
|
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
CRIS Extent: Completers End of Part A
|
54.4 score on a scale
Standard Deviation 10.3
|
52.4 score on a scale
Standard Deviation 8.2
|
|
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
CRIS Extent: Completers End of Part B
|
58.1 score on a scale
Standard Deviation 9.4
|
51.3 score on a scale
Standard Deviation 8.6
|
|
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
CRIS Perceived Limitations: Baseline
|
53.7 score on a scale
Standard Deviation 12.9
|
49.8 score on a scale
Standard Deviation 6.6
|
|
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
CRIS Perceived: Completers End of Part A
|
53.5 score on a scale
Standard Deviation 12.5
|
49.5 score on a scale
Standard Deviation 5.8
|
|
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
CRIS Perceived: Completers End of Part B
|
59.5 score on a scale
Standard Deviation 17.1
|
47.6 score on a scale
Standard Deviation 4.6
|
|
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
CRIS Satisfaction: Completers End of Part A
|
52.0 score on a scale
Standard Deviation 7.7
|
48.3 score on a scale
Standard Deviation 4.7
|
|
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
CRIS Satisfaction: Completers End of Part B
|
55.1 score on a scale
Standard Deviation 12.7
|
48.7 score on a scale
Standard Deviation 5.7
|
Adverse Events
Advanced Upper Limb Prosthetic Device IMU Controlled
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Advanced Upper Limb Prosthetic EMG-PR Controlled
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Advanced Upper Limb Prosthetic Device IMU Controlled
n=39 participants at risk
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled
|
Advanced Upper Limb Prosthetic EMG-PR Controlled
n=13 participants at risk
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Unrelated adverse event
|
2.6%
1/39 • Number of events 1 • Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use.
Definitions of adverse events are consistent with clinicaltrials.gov definitions.
|
0.00%
0/13 • Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use.
Definitions of adverse events are consistent with clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Unrelated adverse event
|
2.6%
1/39 • Number of events 1 • Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use.
Definitions of adverse events are consistent with clinicaltrials.gov definitions.
|
0.00%
0/13 • Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use.
Definitions of adverse events are consistent with clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Adverse Event
|
0.00%
0/39 • Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use.
Definitions of adverse events are consistent with clinicaltrials.gov definitions.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use.
Definitions of adverse events are consistent with clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Adverse event
|
5.1%
2/39 • Number of events 2 • Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use.
Definitions of adverse events are consistent with clinicaltrials.gov definitions.
|
0.00%
0/13 • Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use.
Definitions of adverse events are consistent with clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Adverse event
|
2.6%
1/39 • Number of events 1 • Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use.
Definitions of adverse events are consistent with clinicaltrials.gov definitions.
|
0.00%
0/13 • Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use.
Definitions of adverse events are consistent with clinicaltrials.gov definitions.
|
Additional Information
Linda Resnik, Research Career Scientist
Providence VA Medical Center
Phone: 401-273-7100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place